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Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
Directive 98/27/EC on injunctions for the protection of consumers' interests, repealed by Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers' interests. [6] Directive on alternative consumer dispute resolution, Directive 2013/11/ΕU, issued on 21 May 2013. [7]
The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998. [10] The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB).
Directive 98/71/EC of the European Parliament and of the Council of 13 October 1998 on the legal protection of designs is a European Union directive in the field of industrial design rights, made under the internal market provisions of the Treaty of Rome. It sets harmonised standards for eligibility and protection of most types of registered design
This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC. [6] ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF). [7]
This directive is the codified version of Directive 89/392/EEC as amended by the directives listed above. Machine Directive 1998/37/EC This was amended by the following directive: Directive 98/79/EC has been a minor amendment relating to the exclusion of medical devices. Machinery Directive 98/37/EC remained in force until 29 December 2009.
Directive 2002-87-EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate and amending Council Directives 73-239-EEC, 79-267-EEC, 92-49-EEC, 92-96-EEC, 93-6-EEC and 93-22-EEC, and Directives 98-78-EC and 2000-12-EC of the European Parliament and of the ...
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